Vascular Access Training Simulator System and Transparent Anatomical Model

ABSTRACT

A vascular access training simulator system for training intravascular insertion of a medical device is disclosed. The vascular access training simulator system includes an anatomical training model having clinically relevant ultrasonic properties representative of ultrasonic properties of a human body site for ultrasound imaging. The training model includes a transparent housing, a transparent simulated tissue, at least one simulated blood vessel suspended in the tissue, and a layer of simulated skin covering the housing and the tissue. A first imaging device is records a first video showing a view of an insertion site outside of the simulated skin. A second imaging device records a second video showing the simulated blood vessel through the transparent simulated tissue. A third imaging device is shows an ultrasound view of the simulated blood vessel and the simulated tissue. A monitor displays a composite view of all three videos simultaneously on a single screen.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.16/605,787, filed Oct. 16, 2019, which is a National Stage Entry ofInternational Patent Application No. PCT/US2018/028139, filed Apr. 18,2018, which claims the benefit of U.S. Provisional Application No.62/486,878, filed Apr. 18, 2017, the disclosures of which areincorporated herewith by reference in their entirety.

TECHNICAL FIELD

This disclosure generally relates to a vascular access trainingsimulator system, and more specifically, to a transparent anatomicaltraining model for use in a vascular access training simulator system.

BACKGROUND

Venipuncture is a common medical procedure that is performed to obtainintravenous access for various purposes, including collecting blood oradministering intravenous therapy, among others. Insertion of a medicaldevice, such as a needle, into a patient's vein is often difficult sinceveins can be small in diameter and can be located deep beneath thesurface of the skin. As a result, the intended blood vessel might not behit in a single insertion, thus requiring multiple puncture attempts andcausing excess trauma to the patient. To rectify this problem,ultrasound guidance may be used during the insertion of a needle intothe vasculature of a patient so that the clinician can attempt to trackthe needle through the subcutaneous tissue and into the vessel. Althoughclinicians may currently use ultrasound guidance for venipuncture, theskill level of the clinicians to properly track the needle into the veinvaries greatly, and oftentimes the clinicians do not use the ultrasoundequipment properly. Thus, even with the benefit of ultrasound, avenipuncture procedure may still often be unsuccessful. For example, aclinician may not position the plane or the beam of an ultrasound probeto be directed over the tip of the insertion needle, and thus the needletip location would not be correctly seen by the clinician.

Additionally, even if a clinician is able to use ultrasound tosuccessfully insert a needle into the vasculature of a patient, this maynot be enough to ensure proper placement thereof. This is becausetypically venipuncture of a needle is followed by insertion of aguidewire and/or intravascular catheter in order to provide theclinician with vessel access for the duration of the therapy needed. Thesubsequent insertion of a guidewire and/or catheter that followsvenipuncture has nuances and complications that may also prevent properplacement. For example, if a clinician uses too steep of an insertionangle, the catheter may not thread properly into the vessel.

It is common for clinicians to practice their technique by performing anultrasound guided needle insertion process on a training model beforeperforming the process on a human body. There are conventionalvenipuncture models for this purpose, and some of these conventionalvenipuncture models also allow for training with ultrasound guidance.However, these conventional models do not provide sufficient feedback tothe clinician so that they can visualize what is occurring under theskin with the needle during venipuncture. Moreover, these conventionalmodels do not provide sufficient feedback to the clinician so that theycan visualize what is occurring under the skin with a guidewire orcatheter, if applicable, during a subsequent insertion processes. As aresult, conventional venipuncture models do not provide the feedbacknecessary in order for the clinician to become a more competentinserter.

Consequently, without sufficient feedback to know what went wrong duringa venipuncture training procedure, it is difficult for the clinician toimprove their ultrasound and insertion skills. This problem isespecially prevalent because conventional venipuncture training modelsdo not have simulated tissue that is transparent for allowing aclinician to fully understand what is occurring during the insertion ofa device under the skin, and that has clinically relevant ultrasonicproperties while still closely replicating the look and feel of humantissue and organs. Thus, there is a need for a transparent anatomicalvenipuncture training model that has clinically relevant ultrasonicproperties, and which closely mimics the behavior of human tissue andorgans during needle insertion. Further, there is also a need for avascular access training simulator system having such a transparentanatomical training model.

SUMMARY

The foregoing needs are met, to a great extent, by implementations of avascular access training simulator system according to the presentdisclosure. Such a vascular access training simulator system includes atransparent anatomical training model that provides for the un-aidedvisualization of simulated vasculature, such as synthetic organs or bodytissues. More specifically, the vascular access training simulatorsystem allows a user/clinician to visualize how a medical device, suchas a needle or catheter introducer, functions inside the body andunderneath the surface of the skin when interacting with a blood vesselduring an insertion procedure. The transparency of the model allows theclinician, as well as additional observers, to view underneath thesurface of the skin during a procedure in order to provide definitiveand understandable feedback to the clinician as to what went right butalso what went wrong during a procedure so they can improve theirtechnique. The model is further arranged to provide video recording ofthe procedure so that the clinician or onlookers can view the procedurelive. The procedure can also be recorded for later viewing andevaluation.

In accordance with one implementation, a vascular access trainingsimulator system for simulating intravascular insertion of a medicaldevice comprises an anatomical training model including a transparenthousing, a transparent simulated tissue formed with a ballistics gel, atleast one transparent simulated blood vessel suspended in the ballisticsgel, and a layer of simulated skin covering the housing. The transparentanatomical training model may have clinically relevant ultrasonicproperties representative of ultrasonic properties of a human body sitefor ultrasound imaging. A first imaging device is configured to record afirst video showing a view of an insertion site outside of the simulatedskin. A second imaging device is configured to record a second videoshowing the simulated blood vessel through the transparent simulatedtissue. A third imaging device is configured to record a third videoshowing an ultrasound view of the simulated blood vessel and thesimulated tissue. A monitor may be provided for displaying all threevideos simultaneously on a single screen.

In other implementations, an anatomical training model for intravascularinsertion of a medical device comprises a transparent housing having anopen top end and an open bottom end; a transparent simulated tissueformed with a ballistics gel provided within the housing; at least onesimulated blood vessel suspended in the ballistics gel and configured tobe in fluid communication with a blood analog at venous pressure; and asimulated skin layer removably attached to the top end of the housing.The training model may further have clinically relevant ultrasonicproperties corresponding to ultrasonic properties of a human body sitefor ultrasound imaging.

In other implementations, a training simulator system for simulatingintravascular insertion of a medical device comprises an anatomicaltraining model comprising a puncture insert configured to simulatevasculature of a patient, the puncture insert including a transparentsimulated body tissue, a transparent simulated blood vessel suspended inthe simulated body tissue, and a layer of simulated skin covering aportion of the transparent simulated body tissue; a first imaging deviceconfigured to take a first video depicting a view of an insertion siteon an outer surface of the puncture insert; a second imaging deviceconfigured to take a second video depicting a view of the transparentsimulated blood vessel through the transparent simulated body tissue;and a monitor configured to display the first and second videossimultaneously in real-time.

According to some aspects, a third imaging device is configured to takea third video depicting an ultrasound view of the simulated blood vesseland the simulated body tissue.

According to some aspects, the monitor is further configured to displaya composite view of the first, second and third videos simultaneously inreal-time.

According to some aspects, the system may comprise a handheld ultrasoundprobe.

According to some aspects, the anatomical training model has clinicallyrelevant ultrasonic properties representative of ultrasonic propertiesof a human body site for ultrasound imaging.

According to some aspects, the simulated body tissue includes clinicallyrelevant ultrasonic acoustic and optical properties.

According to some aspects, the simulated body tissue comprises acolloidal suspension of a ballistic gel and poly(methyl methacrylate)(PMMA).

According to some aspects, the anatomical training model furthercomprises an anatomical body part attached to the puncture insert andconfigured to provide a proper orientation for the puncture insert.

According to some aspects, the anatomical training model furthercomprises a support base configured to stably and removably secure thepuncture insert in a predetermined orientation.

According to some aspects, the second imaging device is attached to thesupport base.

According to some aspects, the anatomical training model is configuredto simulate a venipuncture procedure.

According to some aspects, the simulated blood vessel is configured toreceive a blood analog at venous pressure.

According to some aspects, the anatomical training model is configuredto simulate a radial artery puncture procedure.

According to some aspects, the system comprises a pulsatile pump influid communication with the simulated blood vessel for pumping apulsating flow of blood analog through the simulated blood vessel.

According to some aspects, the support base further comprises anadjustment knob configured to selectively control a compression memberto adjust a pulse of the blood analog flowing through the simulatedblood vessel.

In another implementation, an anatomical training model comprises apuncture insert configured to simulate vasculature of a patient, thepuncture insert including a transparent housing having an open top end,a transparent simulated body tissue, at least one transparent simulatedblood vessel suspended in the simulated body tissue, and a simulatedskin layer; the transparent simulated body tissue provided within thehousing; the simulated transparent blood vessel configured to be influid communication with a blood analog; the simulated skin layerremovably attached to the housing and configured to cover a top surfaceof the simulated body tissue; and the training model further havingclinically relevant ultrasonic properties corresponding to ultrasonicproperties of a human body site for ultrasound imaging.

According to some aspects, the simulated body tissue includes clinicallyrelevant ultrasonic acoustic and optical properties.

According to some aspects, the simulated body tissue comprises acolloidal suspension of a ballistic gel and poly(methyl methacrylate)(PMMA).

According to some aspects, the training model further comprises ananatomical body part attached to the puncture insert and configured toprovide a proper orientation for the puncture insert.

According to some aspects, the anatomical body part comprises asimulated hand and a simulated wrist.

According to some aspects, the training model further comprises asupport base configured to stably and removably secure the punctureinsert in a predetermined orientation.

According to some aspects, the simulated blood vessel of the punctureinsert is configured to simulate a vein.

According to some aspects, the simulated blood vessel of the punctureinsert is configured to simulate a radial artery.

According to some aspects, the simulated blood vessel is configured tobe in fluid communication with a pulsatile pump.

In another implementation, a method of making an anatomical trainingmodel comprises the steps of providing a hollow mold block including abottom surface having a bottom opening and a top surface having a topopening; inserting a solid rod through the hollow mold block, the solidrod extending across a length of the mold block; securing a removablecurved lid to the top surface of the mold block to cover the topopening; pouring the molten simulated body tissue material into thebottom opening of the mold and over the solid rod; cooling the moltensimulated body tissue material to set a simulated body tissue; andremoving the solid rod from the set simulated body tissue to create acavity for the simulated vessel to be suspended in the simulated bodytissue.

According to some aspects, the method further comprises the step ofremoving air from the molten simulated body tissue via a vacuum oven toprevent the formation of air bubbles.

According to some aspects, the method further comprises the step ofremoving the curved lid from the mold block to expose the set simulatedbody tissue from the top opening of the top surface of the mold block.

According to some aspects, the mold block comprises a polycarbonateresin.

According to some aspects, the simulated body tissue material comprisesa ballistic gel medium.

According to some aspects, the simulated body tissue material furthercomprises white mineral oil and 2,6-di-tert-butyl-p-cresol mixed with10-40% by weight mineral oil light.

According to some aspects, the simulated body tissue material furthercomprises poly(methyl methacrylate) (PMMA).

According to some aspects, the PMMA comprises beads or powder.

According to some aspects, the simulated body tissue material isconfigured to provide clinically relevant ultrasonic acoustic andoptical properties.

Certain implementations of the vascular access training simulator systemand transparent anatomical model have been outlined so that the detaileddescription below may be better understood. There are, of course,additional implementations that will be described below and which willform the subject matter of the claims. In this respect, it is to beunderstood that the vascular access training simulator system andtransparent anatomical model is not limited in its application to thedetails of construction and to the arrangements of the components setforth in the following disclosure or illustrated in the drawings. Also,it is to be understood that the phraseology and terminology employedherein are for the purpose of description and should not be regarded aslimiting. As such, the conception upon which this disclosure is basedmay readily be utilized as a basis for the designing of otherstructures, methods, and systems for carrying out the several purposesof the vascular access training simulator system and transparentanatomical model. It is understood, therefore, that the claims includesuch equivalent constructions insofar as they do not depart from thespirit and scope of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a vascular access training simulator system accordingto the present disclosure.

FIG. 2 illustrates a schematic top plan view of the vascular accesstraining simulator system according to the present disclosure.

FIG. 3 illustrates a perspective view of an anatomical training modelfor use with the vascular access training simulator system according tothe present disclosure.

FIG. 4 illustrates a side view of the anatomical training model of FIG.3, including a close-up side view of a portion of the anatomicaltraining model.

FIG. 5 illustrates a perspective view of an anatomical training modelwithout an anatomical body limb attached thereto, according to thepresent disclosure.

FIG. 6 illustrates a top plan view of the anatomical training model ofFIG. 5.

FIG. 7 illustrates a front elevation view of the anatomical trainingmodel of FIG. 5.

FIG. 8 illustrates a side elevation view of the anatomical trainingmodel of FIG. 5.

FIG. 9 illustrates a perspective view of a mold used for making ananatomical training model according to the present disclosure.

FIG. 10 illustrates a front elevation view of the training model mold ofFIG. 9.

FIG. 11 illustrates a side elevation view of the training model mold ofFIG. 9.

FIG. 12 illustrates a bottom plan view of the training model mold ofFIG. 9.

FIG. 13 illustrates a video recording output displayed to a user duringor after a simulated venipuncture procedure according to the presentdisclosure.

FIG. 14 illustrates a side perspective view of another implementation ofan anatomical training model for use in a vascular access trainingsimulator system according to the present disclosure.

FIG. 15 illustrates an overhead perspective view of the anatomicaltraining model depicted in FIG. 14.

FIG. 16 illustrates a top plan view of the anatomical training modeldepicted in FIG. 14, without an anatomical body limb attached thereto,according to the present disclosure.

FIG. 17 illustrates a side perspective view of the anatomical trainingmodel depicted in FIG. 16.

FIG. 18 illustrates a top plan view of the anatomical training modeldepicted in FIG. 16, without a puncture insert attached thereto,according to the present disclosure.

FIG. 19 illustrates a bottom view of a portion of a support base of theanatomical training model depicted in FIG. 17.

FIG. 20 illustrates a bottom view of the puncture insert of theanatomical training model depicted in FIG. 14.

FIG. 21 illustrates a perspective view of a portion of the punctureinsert depicted in FIG. 20.

FIG. 22 illustrates a front elevation view of the portion of thepuncture insert of FIG. 21.

FIG. 23 illustrates a video recording output displayed to a user duringor after a simulated radial artery puncture procedure according to thepresent disclosure.

Implementations of the vascular access training simulator system aredescribed with reference to the drawings, in which like referencenumerals refer to like parts throughout.

DETAILED DESCRIPTION

Intravascular medical devices are commonly used to provide access to apatient's vasculature for drawing blood samples, providing therapy, andadministering medicine, among other clinical needs. Examples of suchintravascular medical devices include needle cannulas, catheterintroducers, stylets, guidewires, and other elongate bodies that arepercutaneously inserted into the venous or arterial vasculature of apatient. One challenge common to vascular-based procedures, however, isthe process of inserting an intravascular medical device into a specificdesired location of a patient's vasculature. During venipuncture, forexample, veins may exhibit deformation due to puncturing the venous wallwith a needle. Moreover, insertion of the needle may push veins out ofposition, thus requiring the clinician to use multiple attempts ataccessing a particular blood vessel, instead of accessing it with asingle insertion, and therefore resulting in excess trauma to thepatient.

Moreover, as the intravascular device is inserted through a patient'sskin and tissue, it is difficult for a clinician to ensure that theintravascular device is properly positioned at the desired locationwithin the patient's vasculature. A clinician may use ultrasound imagingto monitor and confirm the proper positioning and placement of theintravascular devices. For example, a clinician performing ultrasoundguided needle insertion can track the needle within the tissues of thepatient to help guide the needle into the desired vasculature. However,vessels can be small in diameter and can be located deep beneath thesurface of the skin. As a result, even with ultrasound guidance, if theclinician is not skilled with proper technique (for example, a clinicianmay not have the plane or beam of the ultrasound probe directed over thetip of the needle, therefore not correctly seeing the needle tiplocation), the intended blood vessel might not be hit in a singleinsertion, thus requiring multiple puncture attempts and causing excesstrauma to the patient.

Additionally, even if the clinician is able to use ultrasound tosuccessfully insert a needle into the vasculature of a patient, this maynot be enough to ensure proper placement if venipuncture is followed byinsertion of a guidewire and/or intravascular catheter. The subsequentinsertion of a guidewire and/or catheter that follows venipuncture hasnuances and complications that may also prevent proper placement. Forexample, if a clinician uses too steep of an insertion angle, thecatheter may not thread properly into the vessel.

The present disclosure provides a vascular access training simulatorsystem for pre-treatment planning and/or for training clinicians how toperform an ultrasound guided needle insertion. The vascular accesstraining simulator system of the present disclosure further allowsclinicians to complete the insertion procedure with subsequent guidewireor catheter device components in order to practice the procedure andbuild further competency by visualizing the insertion in an anatomicaltraining model. Such training is advantageous in order to understandwhat went wrong during the insertion procedure before trying it on ahuman patient. The vascular access training simulator system andanatomical training model may be used to simulate a vascular accessinsertion procedure, such as venipuncture and radial artery puncture.

A vascular access training simulator system 100 according to animplementation of the present disclosure is depicted in FIGS. 1 and 2.The vascular access training simulator system 100 includes an anatomicaltraining model 110, such as a phantom, that simulates a real human bodysite into which an intravascular medical device, such as a needle, canbe inserted. According to one aspect, the vascular access trainingsimulator system 100 is configured to simulate a venipuncture procedure.According to another aspect, the vascular access training simulatorsystem is configured to simulate a radial arterial puncture procedure.

The anatomical training model 110 comprises a puncture insert 115, asupport base 130, and an anatomical model limb or body part 140. Inparticular, the puncture insert 115 includes a transparent housing 120configured to contain transparent simulated body tissue and organs 122.The puncture insert 115 further includes a simulated blood vessel 124and a layer of simulated or synthetic skin 126. The simulated bloodvessel 124 is transparent and is provided within the transparent housing120. More particularly, the simulated blood vessel 124 is suspended inthe transparent simulated body tissue 124 disposed within thetransparent housing 120. A top surface of the transparent housing 120 isopen to provide access to the simulated body tissue 122. The layer ofsynthetic skin 126 covers the transparent housing 120 and thetransparent simulated body tissue 122. Further, the simulated bloodvessel 124 extends through the transparent housing 120 and thetransparent simulated body tissue and organs 122. A plurality ofsimulated blood vessels may be provided at various locations within thetransparent housing 120. Thus, the anatomical training model 110provides a way for a clinician to visualize simulated vasculaturerepresented by the synthetic organs, body tissues, and blood vessels.For instance, the vascular access training simulator system 100 allows aclinician or other user to see how an intravascular medical device, suchas a needle, a catheter, and/or a guidewire, among others, wouldfunction inside the body (i.e., underneath the surface of the skin) wheninteracting with a blood vessel.

The vascular access training simulator system 100 is further configuredto capture and record multiple views of the insertion procedure onvideo, and to display each video recording in real-time on a singledisplay screen or monitor 200, such as a computer screen. This allowsthe clinician or onlookers to easily view the procedure live inreal-time from various different viewpoints without the need for them toturn their head towards separate display screens in order to see eachdifferent view. The procedure may also be recorded for later or repeatviewing and evaluation. In particular, three separate imaging devices,such as a video camera or an ultrasound probe, are configured to captureand record different types of images and/or viewpoints of the needleinsertion procedure. Each of the first, second, and third imagingdevices are arranged in either wired or wireless communication with themonitor 200 in order to display a composite view of the insertionprocedure showing the video from each of the imaging devices on a singledisplay screen, as will be discussed in detail below.

A first imaging device 150, such as a first digital video camera, isconfigured to capture and record a video showing a view of theclinician's hands during an insertion procedure. A second imaging device160, such as a second digital video camera, is configured to capture andrecord a video showing a close-up side view of the simulated bloodvessel 124 extending through the transparent housing 120 and thetransparent simulated body tissue and organs 122. A third imaging device170, such as an ultrasound machine, is configured to capture and recorda video showing an ultrasound guidance view of the simulated bloodvessel 124 during the insertion procedure. The ultrasound machine 170comprises a handheld ultrasound transducer probe or wand 172electrically connected thereto. The handheld ultrasound transducer probeor wand 172 is configured to obtain the ultrasound guidance view of thesimulated blood vessel. The ultrasound probe 172 may also be used withan ultrasound gel to increase conduction between ultrasound waves andthe simulated body tissue. The ultrasound machine 170 may furthercomprise an ultrasound display screen 174 configured to display theultrasound guidance view during needle insertion into the punctureinsert 115 and the associated simulated body tissue 122 and simulatedblood vessel 124.

As previously described, the first, second, and third imaging devicesare configured to capture and record real-time video depicting differentviews of the anatomical training model 110 for displaying a compositeview of the videos on the monitor 200 during a simulated vascularinsertion procedure, such as a venipuncture procedure. To produce thecomposite view, the videos obtained from the first, second, and thirdimaging devices are fed directly to the monitor 200, and are synced andmerged into a single video file for final viewing and evaluation of theinsertion procedure. In some aspects, the monitor 200 may be configuredto record the composite view of the videos. In other aspects, a screenrecording device may be connected to the monitor 200 for recording thecomposite view of the videos provided by the first, second, and thirdimaging devices.

The puncture insert 115 is configured to retain transparency in visiblelight so that the intravascular medical device and simulated bloodvessel 124 are visible to the clinician during the insertion procedure.Additionally, the puncture insert 115 has clinically relevant ultrasonicproperties (i.e., realistic anatomical features). Thus, the trainingmodel is configured to be visible to a clinician and have video recordedin three distinct ways: (1) a video of the insertion site taken by thefirst imaging device 150 and viewed from outside the synthetic skin 126covering both the transparent housing 120 and the transparent simulatedbody tissue 122; (2) a video of the simulated blood vessel 124 taken bythe second imaging device 160 and viewed through both a side wall of thetransparent housing 120 and the transparent simulated tissue 122; and(3) a video of the simulated blood vessel 124 taken by the third imagingdevice 170 and viewed using ultrasound.

The puncture insert 115 may be stably yet removably mounted on a supportbase 130. In some aspects, a light source 112, such as a dimmable lightstrip, may be mounted directly to the transparent housing 120 of thepuncture insert 115 so that the simulated vessel 124 can be sufficientlyilluminated to ensure that activity of the medical device within thesimulated blood vessel and body tissue can be adequately visualized andrecorded. In other aspects, the light source 112 may be mounted on thesupport base 130 at a location adjacent to the transparent housing 120for providing sufficient illumination to the simulated blood vessel andbody tissue. Additionally, the vascular access training simulator system100 may include a microphone 180 configured to record a clinician'saudible comments and observations during the insertion procedure.

Further, the anatomical training model 110 may comprise an anatomicalbody part 140, such as an anatomical upper arm model, connected to anend of the transparent housing 120 in order provide a basis for properorientation of the puncture insert 115 during a vascular insertionprocedure. In particular, the anatomical body part 140 is configured tobe mounted to the transparent housing 120 in an manner corresponding toan orientation of the synthetic blood vein 124 extending through thetransparent housing 120. Such an arrangement is well suited for use witha peripherally inserted central catheter (PICC). It should also beappreciated that the training model 110 may include a variety ofanatomical model limbs and body parts 140 connected to the transparenthousing 120. For instance, as shown in FIG. 1, an anatomical upper armmodel 140 having a clenched fist is illustrated, and in FIG. 2, ananatomical upper arm model 140 having an open fist is illustrated.

FIG. 3 depicts the anatomical training model 110 together with the firstand second imaging devices 150, 160 of the vascular access simulatorsystem. The transparent housing 120 and simulated body tissue 122 iscovered by a layer of the synthetic skin 126. The first imaging device150 is configured to point toward a top of the housing 120 and the layerof synthetic skin 126 such that both the clinician's hands and theintravascular device are viewed and recorded during the insertionprocedure. The second imaging device 160 is configured to point toward aside of the transparent housing 120 such that a piercing portion of theinsertion device is viewed and recorded together with the transparentsimulated tissue 122 and the at least one synthetic vein 124.

An insertion site view 151 taken from the first imaging device 150 isillustrated in FIG. 3. As shown, the first imaging device 150 isconfigured to capture a view of the insertion site from outside thesynthetic skin 126 covering the top of the transparent housing 120 andthe simulated body tissue 122. In order to achieve the insertion siteview 151, the first imaging device 150 is raised above the top plane ofthe transparent housing 120 and pointed toward a needle insertion siteon the synthetic skin 126. FIG. 4 depicts a blood vessel view 161 takenfrom the second imaging device 160. As shown, the second imaging device160 is configured to capture a view of the simulated blood vessel 124through the transparent housing 120 and the transparent simulated tissue122. In order to achieve the blood vessel view 161, the second imagingdevice 160 is mounted to the support base 130 and pointed toward thesimulated blood vessel 124 within the transparent housing 120. Moreover,as shown in FIG. 4, the anatomical body part 140 is mounted to thetransparent housing 120 in an anatomical orientation relative to thesimulated blood vessel 124.

It should also be appreciated that various types of simulatedvasculature of the training model 110 may be provided. For instance, thetraining model may include a plurality of synthetic veins of varioussized diameters. In some implementations, for example, the trainingmodel 110 may include vasculature of the lower arm in order to simulateIV procedures. In other implementations, the training model 110 mayinclude vasculature of an anatomical model arm and half a chest that canbe used to simulate both PICC and midline procedures. In otherimplementations, the training model 110 may include an anatomical torsomodel to simulate central venous catheter (CVC) and hemodialysisprocedures.

The synthetic blood vessel 124 is configured to be in fluidcommunication with a blood analog at venous pressure. The blood vessel124 includes a blood analog pressure input 134 configured to connect toa fitting, such as a luer fitting, so that a supply of analog blood canpressurize the blood vessel 124. The addition of analog blood to thesimulated blood vessel 124 increases ultrasound visibility, and alsocreates simulated blood flash upon venipuncture.

Referring to FIGS. 5-8, the second imaging device 160 and thetransparent housing 120 of the anatomical training model 110 are bothshown secured to the support base 130. The layer of synthetic skin 126covering the top of the housing 120 may be removably secured thereto bya plurality of clip fasteners 136 attached to the housing 120. As notedabove, the puncture insert 115 is stably yet removably mounted on asupport base 130. In particular, the transparent housing 120 may beremovably secured in place on the support base 130 via fasteners 132,such as screws or bolts. Further, the second imaging device 160, whichis configured to capture and record a side view of the simulated bloodvessel 124 through the transparent housing 120 and the transparent bodytissue 122, is shown pivotably connected to the support base 130 inorder to provide an adjustable viewing angle.

As previously described, the puncture insert 115 comprises a transparenthousing 120 having transparent simulated body tissue and organs 122. Thehousing 120 includes a first opposing pair of walls 120 a, and a secondopposing pair of walls 120 b that are perpendicularly connected to thefirst opposing pair of walls 120 a by fasteners, such as screws orbolts. In some implementations, the first and second pairs of walls 120a, 120 b of the housing 120 form a hollow rectangular encasementconfigured to contain the transparent simulated body tissue 122, whereina top of the housing and a bottom of the housing are open to expose thesimulated body tissue. The transparent housing 120 further comprises atleast one transparent simulated blood vessel 124 and a layer ofsynthetic skin 126 covering a top of the housing 120 and the simulatedbody tissue 122. The transparency of the training model 110 allows theclinician, as well as additional observers, to view underneath thesurface of the synthetic skin 126 during or after a venipunctureprocedure in order to provide feedback to the clinician, while stillclosely replicating needle insertion into human tissue and organs.

The simulated tissue and organs 122 of the puncture insert 115 comprisea transparent tissue-mimicking gelatin configured to imitate theultrasound properties of human tissue, the stiffness and feel of humantissue, and the penetration forces and characteristics of human tissueduring venipuncture. This tissue-mimicking gelatin, or ballistic gel,maintains the desired transparency while also simulating humansubcutaneous fat and connective tissue. The simulated tissue material122 may comprise a mixture of layers with various geometries havingdifferent concentrations and/or formulations of the tissue materials inorder to simulate different ultrasonic acoustic and optical properties.The simulated tissue material also allows for repeated sticks of thevascular access device.

A process for making the puncture insert 115 includes using a mold block120′ comprising a rectangular polycarbonate resin, such as Lexan™,having a curved removable lid 121. As shown in FIGS. 9-12, the mold alsoincludes a solid rod 138 for creating a cavity for the simulated vessel124 after molding. The process comprises pouring molten simulated tissuematerial into the mold from an open bottom section over the solid rod138. Air is removed from the simulated tissue 122 via a vacuum ovenprior to molding in order to prevent the formation of air bubbles whichcan obstruct the view of the camera and create ultrasound artifacts.

All tissue material layers use a base material of Perma-Gel ballisticsgel medium comprising white mineral oil and 2,6-di-tert-butyl-p-cresolmixed with 10-40% by weight mineral oil light. In one implementation,25% by weight mineral oil light may be used. During testing, thisconcentration was found to exhibit representative needle penetrationvalues when compared to human tissue at room temperature. Variouscombinations of two types of Poly(methyl methacrylate) (PMMA) are addedto create the different clinically relevant ultrasonic acoustic andoptical properties of the gel layers (refer to Table 1 shown below). Insome implementations, PMMA beads having an average MW of 35,000 andtypical particle size of 50 to 150 micron are used. In otherimplementations, powdered PMMA may also be used to simulate thesonographic characteristics of living tissue. In still otherimplementations, the transparent simulated tissue, the simulated bloodvessel, and/or the simulated skin layer have clinically relevantultrasonic properties corresponding to ultrasonic properties of a humanbody site for ultrasound imaging.

TABLE 1 Combinations of Tissue Material Layers Description of TissueMaterial Critical Ultrasonic Layer Simulated Tissue Material Compositionand Optical Properties White Connective tissue Base material withHyperechoic Connective present in PMMA powder (brighter, white) Streakssubcutaneous added at a under ultrasound; fat between the concentrationof translucent epidermis/dermis between 2-10% of and target vessel gelweight (i.e., 5% of gel weight) White/Clear Connective tissue Basematerial with Hyperechoic Layer Potting surrounding vessel PMMA beadsadded (brighter, white) Vessel at a concentration of under ultrasound;between 0.1-1% of transparent gel weight (i.e., 0.45% of gel weight)Gray/Black Contrasting Base material with Anechoic (black); Primarysubcutaneous fat PMMA powder translucent Material layers added at aconcentration of between 0.1-1% of gel weight (i.e., 0.3% of gel weight)

After the molten simulated tissue 122 is added to the mold block 120′,it is cooled and then the rod 138 is removed from the block to leave anopening for the simulated blood vessel 124 to be suspended in thesimulated tissue 122. The simulated vessel 124 may be a synthetic veintube having properties that simulate living tissue. The curved lid 121is then removed and the mold block 120′ is inverted to create acurvature that mimics the curvature of a body part, such as an arm. Thisalso allows for the clinical practice of compressing the vessels withthe ultrasound probe, which is a technique clinicians can use duringvenipuncture to distinguish between veins, which compress, and arteries,which do not compress. Once the lid 121 is removed, the polycarbonateresin mold 120′ forms the training model housing 120, which contains thesimulated vessel 124 and simulated tissue 122. The housing may then beattached to the support base 130 via fasteners, such as screws or bolts.Similarly, an anatomical body part 140, such as a mannequin arm, maythen be attached to the housing 120 to assist with orientation aspreviously described. The layer of synthetic skin 126 is then clippedonto the top of the housing 120 by using fastening clips 136 attached toside walls of the housing.

Turning to FIG. 13, the display screen or monitor 200 shows a real-timeview or recording of a composite image formed from the first, second,and third imaging devices of the vascular access training simulatorsystem. As previously described above, the three imaging devices arearranged to provide the clinician with different types of images andviewpoints. Further, each video image is displayed simultaneously on asingle display screen. For instance, the first imaging device 150 isconfigured to capture a view of the clinician's hands during thetraining procedure, which is depicted in a first section 150 a of thedisplay screen 200.

The first imaging device 150 is configured to capture video of theclinician holding both the ultrasound imaging probe 172 as well as anintravascular medical device, such as a catheter insertion needle. Thesecond imaging device 160 is configured to capture a side view of thesynthetic vessel 124 inside the anatomical model as viewed through thetransparent housing 120 and the transparent simulated tissue 122, whichis depicted in a second section 160 a of the display screen 200. Thethird imaging device 170 is arranged to capture a recording of theultrasound monitor's image of the anatomic model along an ultrasoundplane 175, which is depicted in a third section 170 a of the displayscreen 200. The vascular access training simulator system is furtherconfigured to sync and merge the three separate video recordings into asingle video file for final viewing and evaluation of the insertionprocedure.

Turning to FIGS. 14 and 15, another implementation of an anatomicaltraining model 1110 of a vascular access training simulator system isdepicted. The anatomical training model 1110 may be configured to mimicvenipuncture and/or radial arterial insertion of a medical device, suchas a needle. The anatomical training model 1110 comprises an anatomicalpuncture insert 1115, a support base 1130, and an anatomical model limb1140. The anatomical model limb 1140, such as a model hand, is removablyattachable to the puncture insert 1115 to provide a basis for properorientation of the puncture insert. As will be discussed below ingreater detail, the puncture insert 1115 comprises a transparent housing1120, a transparent simulated body tissue 1122, a simulated blood vessel1124, and a layer of synthetic skin 1126. Further, the puncture insert1115 is removably attachable to the support base 1130 so that it can bereplaced with a new insert as needed after several insertions of theneedle into the simulated artery and tissue have been performed.

Similar to the training simulator system previously described above, afirst imaging device 1150, such as a first digital video camera, isconfigured to capture and record a video showing a view of theclinician's hands during the insertion procedure. A second imagingdevice 1160, such as a second digital video camera, is configured tocapture and record a video showing a close-up view of the simulatedblood vessel 1124 extending through the transparent housing 1120 and thetransparent simulated body tissue and organs 1122. The first imagingdevice 1150 is configured to point toward an outer top surface of thepuncture insert 115 such that the layer of synthetic skin 1126, theclinician's hands, and the intravascular device are all viewed andrecorded during the insertion procedure. The second imaging device 1160is provided in a compartment of the support base 1130, as will bediscussed in greater detail below.

The support base 1130 comprises a stabilizing plate, a stabilizingstand, and a fluid reservoir 1131 configured that hold a supply offluid, such as synthetic blood. The support base 1130 also includes aflow outlet 1133 and a flow inlet 1134. The flow outlet 1133 is in fluidcommunication with the fluid reservoir 1131 and a pulsatile arterialsimulation pump. The flow inlet 1134 is in fluid communication with thepulsatile pump and the simulated blood vessel 1124 of the punctureinsert 1115.

As shown in FIGS. 14 and 15, the anatomical model limb 1140 comprises amodel hand attached to the puncture insert 1115 in a flexed position tosimulate radial artery puncture. In this arrangement, the anatomicalpuncture insert 1115 is a simulated forearm, and the simulated bloodvessel 1124 within the simulated forearm is a simulated artery. Thesimulated forearm extends about 3.5 inches in length from the wrist ofthe anatomical body part 1140, which represents the location where theradial artery is most superficial and used for radial arterycatheterization.

To mimic a radial arterial insertion, the flow of synthetic bloodthrough the simulated blood vessel 1124 of the puncture insert 1115 ispressurized by the pulsatile pump to provide a palpable pulsatile flow.Accordingly, the pulsatile pump is configured to draw simulated bloodfrom the reservoir 1131 and into the pump via the flow outlet 1133, andpump the simulated blood through the simulated blood vessel 124 via theflow inlet 1134 before returning the simulated blood back to the fluidreservoir. Flexible fluid tubing, such as transparent silicon tubing,may be used to transport the simulated blood through the system. Thepulsation of the simulated blood sent from the pulsatile pump throughthe simulated blood vessel 1124 mimics the flow of blood through anartery. Consequently, expansion of the pressurized simulated artery canbe felt by the clinician through the simulated tissue 1122 and thesynthetic skin cover 1126 of the puncture insert 1115. This tactileresponse helps the clinician locate the simulated artery in the forearm.Further, the pulse of the simulated blood flow can be adjusted bycompressing the connector tubing via an adjustment knob 1137.

Referring to FIGS. 16 and 17, the anatomical training model is depictedwith the anatomical model limb detached from the puncture insert 1115. Ablood vessel inlet tubing 1135 is connected to a blood vessel inlet endof the simulated blood vessel 1124 within the puncture insert 1115, anda blood vessel outlet tubing 1136 is connected to a blood vessel outletend of the simulated blood vessel within the puncture insert. The bloodvessel inlet and outlet tubes 1135, 1136 may be molded to the bloodvessel inlet and outlet ends, respectively, of the simulated bloodvessel. Additionally, the support base 1130 includes a recess 1132configured to removably receive the fluid reservoir 1131.

A compartment 1145 is provided within the support base 1130 and locateddirectly underneath the puncture insert 1115. The location of thecompartment 1145 is shown in FIG. 18, in which the puncture insert isremoved from the support base 1130. The compartment 1145 is configuredto removably receive the second imaging device 1160 in an orientationpointing upward, i.e., toward a bottom surface of the puncture insertwhen the puncture insert is attached to the support base. A transparentprotective barrier 1146, such a clear acrylic sheet, covers thecompartment 1145. The protective barrier 1146 is configured to providethe compartment with a water-tight seal in order to prevent fluid ordirt or debris from damaging the second imaging device 1160 and/orblocking a view of the video obtained from the second imaging device.The compartment 1145 may include a drainage tube inlet configured drainaway any fluid that enters the compartment.

An underside view of a portion of the support base 1130 is shown in FIG.19. A compression member 1139, such as an adjustable clamp, is shownconnected to the adjustment knob 1137 and is configured to selectivelycompress a section of the blood vessel inlet tubing 1135 when theadjustment knob is turned. Thus, a user is able to adjust the pulse ofsimulated blood flow through the simulated blood vessel 1124 bymanipulating the adjustment knob 1137 to adjust the amount ofcompression applied by the clamp 1139 to the vessel inlet tubing 1135.

An underside view of the puncture insert 1115 is shown in FIG. 20, inwhich the transparent housing 1120, the transparent simulated bodytissue 1122, and the simulated blood vessel 1124 are all depicted. Assimilarly described in detailed above, the simulated body tissue 1122 ofthe puncture insert 1115 comprises a transparent tissue-mimickinggelatin configured to imitate properties of human tissue. Suchproperties include the stiffness and feel of human tissue, thepenetration forces and characteristics of human tissue during needlepuncture, and the ultrasound properties of human tissue, among others.The tissue-mimicking gelatin, or ballistic gel, maintains the desiredtransparency while also simulating human subcutaneous fat and connectivetissue. The simulated tissue material 1122 may comprise a mixture oflayers with various geometries having different concentrations and/orformulations of the tissue materials in order to simulate differentproperties while also allowing for repeated sticks of the insertiondevice.

The puncture insert 1115 shown in FIG. 20 comprises a simulated artery1124, which may include a transparent silicon tubing that is moldedwithin the clear tissue-mimicking gelatin of the simulated body tissue1122. The simulated artery 1124 includes an inlet end that is in fluidcommunication with the blood vessel inlet tubing 1135, and an outlet endthat is in fluid communication with the blood vessel outlet tubing 1136.Additionally, a mirror 1125 is implanted within the clear ballistic gelat approximately a 45 degree angle relative to a sidewall of thetransparent housing 1120. The angled mirror 1125 allows for the secondimaging device 1160, which is provided within the support base 1130 andlocated below the bottom surface of the puncture insert 1115, to captureand record a side view of the simulated vessel 1124 during an insertionprocedure. Additionally, the location of the second imaging device 1160also allows for a direct view of the bottom of the simulated vessel 1124to be captured and recorded during an insertion procedure. The bottomsurface of the puncture insert 1115 defines a transparent floor thatallows for the second imaging device 1160 housed inside the support base1130 to capture the side view of the simulated vessel via the mirror1125, as well as the bottom view of the vessel via direct line-of-sight.FIGS. 21 and 22 depict the simulated body tissue 1222 without thetransparent housing in which its contained. As shown, a vesselthrough-hole 1124 a is provided in the simulated body tissue 1222 andconfigured to receive the simulated blood vessel 1124. A mirrorthrough-hole 1125 a is similarly provided in the simulated body tissue1222 and configured to receive the mirror 1125.

The video captured and recorded from the first and second imagingdevices 1150, 1160 may be displayed in real-time on a display screen ormonitor 2000, as depicted in FIG. 23. In particular, the display monitor2000 is configured to show a real-time video or a pre-recorded video ofa composite view formed from the videos captured by the first and secondimaging devices. Thus, both imaging devices are configured to providethe clinician with different types of video images and viewpoints, andeach video image may be displayed simultaneously on a single displayscreen. For example, the separate video recordings taken by the firstand second imaging devices 1150, 1160 may be synced and merged into asingle video file for final viewing and evaluation of the insertionprocedure on the single display screen.

The first imaging device 1150 is configured to capture a view of theclinician's hands and the intravascular medical device relative to theinsertion site during the training procedure, which is depicted in afirst section 1150 a of the display screen 2000. The second imagingdevice 1160 is configured to capture a side view of the synthetic vessel1124 inside the anatomical model as viewed through the transparenthousing 1120 and the transparent simulated tissue 1122, which isdepicted in a second section 1160 a of the display screen 2000. Thesecond section 1160 a of the display screen further includes both thebottom view 1161 of the simulated vessel 1124 as well as the side view1162 of the simulated vessel via the mirror 1125.

According to other aspects of the anatomical training model, an ulnarartery may be simulated by continuing the pulsatile flow and looping thesilicon fluid tubing inside the puncture insert to allow for theclinician to simulate an “Allen Test” prior to insertion. Such anarrangement may be used to confirm whether the ulnar artery supply tothe hand is sufficient so that the radial artery can be cannulated andcatheterized. In other aspects, the anatomical training model mayinclude both a simulated vein and a simulated artery. Further, theanatomical training model may include other anatomical features, such asnerves, muscles, and bones.

The many features and advantages of the vascular access trainingsimulator system and anatomical training model are apparent from thedetailed specification, and thus, the claims cover all such features andadvantages within the scope of this application. Further, numerousmodifications and variations are possible. As such, it is not desired tolimit the vascular access training simulator system and anatomicaltraining model to the exact construction and operation described andillustrated. Accordingly, all suitable modifications and equivalents mayfall within the scope of the appended claims.

What is claimed is:
 1. A method of simulating intravascular insertion ofa needle, the method comprising: providing a training simulator systemcomprising an anatomical training model including a puncture insertsimulating vasculature of a patient, the puncture insert including atransparent simulated body tissue, a transparent simulated blood vesselsuspended in the simulated body tissue, and a layer of simulated skincovering a portion of the transparent simulated body tissue; capturing afirst video using a first imaging device, the first video depicting aview of an insertion site on an outer surface of the puncture insert;capturing a second video using a second imaging device, the second videodepicting a view of the transparent simulated blood vessel through thetransparent simulated body tissue; displaying a composite view of thefirst and second videos simultaneously in real-time on a monitor;guiding the needle, via the real-time composite view, through thetransparent simulated body tissue; and inserting the needle, via thereal-time composite view, into the simulated blood vessel.
 2. The methodof simulating intravascular insertion of a needle according to claim 1,further comprising capturing a third video using a third imaging device,the third video depicting an ultrasound view of the simulated bloodvessel and the simulated body tissue.
 3. The method of simulatingintravascular insertion of a needle according to claim 2, furtherdisplaying a composite view of the first, second and third videossimultaneously in real-time on the monitor.
 4. The method of simulatingintravascular insertion of a needle according to claim 2, wherein thethird imaging device includes a handheld ultrasound probe.
 5. The methodof simulating intravascular insertion of a needle according to claim 1,wherein the simulated body tissue comprises a colloidal suspension of aballistic gel and poly(methyl methacrylate) (PMMA).
 6. The method ofsimulating intravascular insertion of a needle according to claim 1,wherein the anatomical training model further comprises an anatomicalbody part attached to the puncture insert and configured to provide aproper orientation for the puncture insert.
 7. The method of simulatingintravascular insertion of a needle according to claim 1, wherein theanatomical training model further comprises a support base configured tostably and removably secure the puncture insert in a predeterminedorientation.
 8. The method of simulating intravascular insertion of aneedle according to claim 7, wherein the second imaging device isattached to the support base.
 9. The method of simulating intravascularinsertion of a needle according to claim 1, wherein the anatomicaltraining model is configured to simulate a radial artery puncture site.10. The method of simulating intravascular insertion of a needleaccording to claim 9, further comprising a pulsatile pump in fluidcommunication with the simulated blood vessel for pumping a pulsatingflow of blood analog through the simulated blood vessel.
 11. The methodof simulating intravascular insertion of a needle according to claim 10,wherein the support base further comprises an adjustment knob configuredto selectively control a compression member to adjust a pulse of theblood analog flowing through the simulated blood vessel.
 12. A method ofmaking a puncture insert of an anatomical training model, the methodcomprising: providing a hollow mold block including a bottom surfacehaving a bottom opening and a top surface having a top opening;inserting a solid rod through the hollow mold block, the solid rodextending across a length of the mold block; securing a removable curvedlid to the top surface of the mold block to cover the top opening;pouring a molten simulated body tissue material into the bottom openingof the mold block and over the solid rod; cooling the molten simulatedbody tissue material to set a simulated body tissue; and removing thesolid rod from the set simulated body tissue to create a cavity for thesimulated vessel to be suspended in the simulated body tissue.
 13. Themethod of making a puncture insert according to claim 12, furthercomprising a step of removing air from the molten simulated body tissuevia a vacuum oven to prevent the formation of air bubbles.
 14. Themethod of making a puncture insert according to claim 13, furthercomprising a step of removing the curved lid from the mold block toexpose the set simulated body tissue from the top opening of the topsurface of the mold block.
 15. The method of making a puncture insertaccording to claim 12, wherein the mold block comprises a polycarbonateresin.
 16. The method of making a puncture insert according to claim 12,wherein the simulated body tissue material comprises a ballistic gelmedium.
 17. The method of making a puncture insert according to claim16, wherein the simulated body tissue material further comprises whitemineral oil and 2,6-di-tert-butyl-p-cresol mixed with 10-40% by weightmineral oil light.
 18. The method of making a puncture insert accordingto claim 16, wherein the simulated body tissue material furthercomprises poly(methyl methacrylate) (PMMA).
 19. The method of making apuncture insert according to claim 18, wherein the PMMA comprises beadsor powder.
 20. The method of making a puncture insert according to claim12, wherein the simulated body tissue material is configured to provideclinically relevant ultrasonic acoustic and optical properties.